Food and Drug

Arnall Golden Gregory's Food and Drug Practice Team advise food, pharmaceutical, medical device, biologics and cosmetic companies on all issues relating to federal government regulation by the U.S. Food and Drug Administration, the U.S. Drug Enforcement Administration, the U.S. Consumer Product Safety Commission, and the U.S. Customs and Border Protection, as well as state regulatory bodies.  The Team, nationally recognized, is regarded by clients to be "practical," "cost-effective," and "responsive."  AGG lawyers work to achieve the clients' objective by thinking "not if, but how."

AGG's Food and Drug Practice Team counsels clients in such areas as product development and approval, clinical trials, labeling and advertising, orphan products, exclusivity, clinical investigators, GRAS petitions, product lifecycle management, compliance and inspections, to name a few.  Our clients are diverse, including manufacturers, distributors, and trade associations, based both in and outside the U.S. and from early-stage to NYSE-traded multinational firms.  We also advise other law firms, healthcare communications companies, consultants, and financial institutions on due diligence, investigations, and in-house training.

AGG's Food and Drug Practice Team collaborates with other AGG groups to better serve clinical needs including, but not limited to, Corporate (e.g., licensing, distribution, quality and clinical trial agreements), Intellectual Property (e.g., patent certification, patent prosecution, trademark registration, and Lanham Act litigation), Healthcare and Government Investigations (e.g., fraud and abuse counseling and defense) and International Business (e.g., Foreign Corrupt and Practices Act, European Union Directives) and Logistics and Transportation (e.g., Customs issues).